Identification of a Biomarker Predictive of Evolution of Parkinson Disease

NCT ID: NCT03230526

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-16
• Study Completion Date: 2024-05-06

Brief Summary

Phase II, Open-labeled, Prospective, Multi-center study of assessing the link between microglial activation and dopaminergic denervation kinetics in the early stage of Parkinson disease, by using the imaging of [18F]DPA-714 a new ligand of Translocator Protein-18 kDa (TSPO) by Positron Emission Tomography (PET).

Detailed Description

The Parkinson's disease ( MP) is a frequent but heterogeneous neurodegenerative disease in term of clinical presentation(display) and evolutionary profile. The therapeutic coverage(care) of the patients would thus be personalized Such an approach remains still in its infancy in 2017. Better know the factors which determine the evolutionary clinical subcategories is a major question of the current researches on the Parkinson disease. Nigrostriaial inflammation is an interesting candidate. Microglia activation is closely associated with the degenerative process.

Development of the molecular imaging allows to study nigrostriatal inflammation in vivo in human by positron emission tomography (PET) by using the radiotracer of the protein of translocation of 18KDa ( TSPO), considered as a marker of microglia activation Some studies showed an increase of the inflammation in the striatum and in the substantia nigra, the sites of the dopaminergic degeneration (The lesional core of the Parkinson disease is the damage of the dopaminergic nigrostriatale way). However data remain rare and concern small number of patients. Some data are inconsistent because of problems of specificity of the ligands used and variation between populations of studied patients (duration of disease evolution).

In this study, investigators suggest studying by imaging TEP using a ligand new of the TSPO, [18F]DPA-714, microglial brain activation in the early stage of the Parkinson disease and determine wether it is predictive of speed of disease progression.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

[18F]DPA-714 PET scan

One PET scan using [18F]DPA-714 is done at M2 between two [123I]FP-CIT scan (DaTscan) done at M1 and M23.

Neuropsychological assessment is done at M0, M18 and M24

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients having a Parkinson's disease diagnosed according to the criteria UKPDSBB.
• Diagnosis done less than three years before the date the inclusion.
• Patient Age at diagnosis : between 40 and 65 years.
• Absence of clinical arguments for an associated neurovascular pathology.
• Written consent obtained.
• HAB polymorphism in the genotyping of TSPO gene.
• Brain MRI without following abnormalities: cortical or sub-cortical atrophy or hippocampal atrophy (Scheltens score ≥2), vascular encephalopathy (Fazekas score > 2, > 10 microbleed) or showing signs in favour of atypical parkinson syndrome.

Exclusion Criteria

• Pregnant woman
• Minor
• Adult protected by the law
• Contraindication to PET-scan
• Contraindication to brain MRI
• History of inflammatory or dysimmune chronic disease
• History of psychiatric disease or drug addiction
• History of cognitive disorders (MMS<26)
• Hypersensibility to iodine derivates or one of these components
• Long-term Treatments which can interfere in neuroinflammation process
• Treatments / substances susceptible to interfere with the 18F-DPA-714
• TSPO gene Polymorphisms rs6971 corresponding to groups of affinity of low affinity (LAB=Low Affinity Binder) or moderated MAB = Mixed Affinity Binder)
• Modification of diagnosis of Parkinson disease during follow-up, in particular towards an atypical parkinson-like syndrome

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Nantes

Nantes, , France

Centre Eugène Marquis

Rennes, , France

CHU de Rennes

Rennes, , France

CHU de Tours

Tours, , France

Countries

France

Other Identifiers

2017-000411-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RC17_0012

Identifier Type: -

Identifier Source: org_study_id